On December 27, 2022, the Brazilian Patent and Trademark Office (BRPTO) published Ordinance No. 79/2022, which establishes updates regarding the fast-track examination programs in Brazil.

The Ordinance No. 79 entered into force on January 01, 2023, revoking the previous Ordinance 54/2021, which also dealt with fast-track examination programs in Brazil.

According to this new Ordinance, the modality specifically directed to the requirement of fast-track examination for patent applications related to technology for the treatment of COVID-19 was withdrawn.

On the other hand, patent applications applicable to the following new modalities will be entitled to fast-track examination under this Ordinance 79:

• • Technology Resulting from Public Financing

• • Technology Available on The Market

In addition, under the pre-existing modality of Technology for Health Treatment, it was included the provision for patent applications whose object is related to pharmaceutical products and processes and equipment and/or materials for use in health for diagnosis, prophylaxis and/or treatment of technologies related to public health emergencies of national importance, pursuant to Decree 7616/2011, or international, when declared by the World Health Organization.

We recall that the fast-track examination can still be requested by the Applicant in the following circumstances, according to this new Ordinance:

• • when the Applicant is a natural person: (i) older than 60 years old; (ii) with disabilities; or (iii) with a serious illness;

• • when the application is filed by Brazilian micro and medium-sized entities;

• • when the Applicant is a legal person and belongs to a Brazilian Scientific, Technological and Innovation Institute (ICT);

• • when the application belongs to a Brazilian Startup;

• • when the application is directed to a pre-selected green technology, referring to (i) alternative energy; (ii) transportation; (iii) energy conservation; (iv) waste management; and (v) sustainable agriculture;

• • when the application relates to health technologies for the diagnosis, prophylaxis and/or treatment of (i) Acquired Immunodeficiency Syndrome (AIDS), (ii) cancer, (iii) rare diseases (i.e., diseases affecting 65 per each 100,000 people); or (iv) (pre-defined) neglected diseases;

• • when the Applicant is in need of a granted patent to obtain financial resources from official national credit institutions, as an economic subsidy, financing or partnership, or originating from investment funds, for the use of the respective product or process;

• • unauthorized reproduction and/or commercialization of the subject matter object of a patent application is taking place in Brazil; and

• • when the patent application refers to an object whose patent protection has been first requested in Brazil, i.e., the application belongs to a family whose patent prosecution has been initiated in Brazil.

Moreover, third parties may request the fast-track examination in the following situations:

• • when the application relates to health technologies for the diagnosis, prophylaxis and treatment of (i) Acquired Immunodeficiency Syndrome (AIDS), (ii) cancer, (iii) rare diseases (i.e., diseases affecting 65 per each 100,000 people), or (iv) (pre-defined) neglected diseases;

• • when third parties are being accused of unauthorized reproduction and/or commercialization of the subject matter of a patent application; and

• • when third parties, in good faith, simultaneously (i) explored in the country all or part of the subject matter of a patent application prior to its filing date; and (ii) have their rights to continue the exploitation demonstrably threatened or limited.

Still, the fast-track examination may be requested by:

• • the Ministry of Health when the application relates to pharmaceutical products and processes, equipment and/or materials for use in health referring to the assistance policies of the Ministry of Health and considered strategic within the scope of the Public Healthcare System (SUS);

• • the BRPTO, when the application relates to technologies of national emergency or public interest.

Click here to read the complete Ordinance (in Portuguese).

 

 

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